Job Title: Sr. Quality Engineer Medical Device
Location: Northridge, CA (Fully Onsite)
Type: 12-Month W2 Contract
Summary:
Were seeking an experienced Senior Quality Engineer to support the full product development lifecycle for implantable and electro-mechanical medical devices. The ideal candidate will have strong expertise in Design Controls, Risk Management (FMEA, Hazard Analysis), and Validation (TMV, IQ/OQ/PQ), ensuring compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, and EU-MDR standards.
Key Skills:
Design Control & Regulatory Compliance (ISO 13485, 21 CFR 820, EU-MDR)
Risk Management (FMEA, Hazard Analysis)
Electro-mechanical
Design Verification & Validation Testing
Process Validation (TMV, IQ/OQ/PQ)
Supplier Qualification & Design Transfer
Problem Solving / CAPA / Continuous Improvement.
Preferred:
Experience with IEC 62304 and IEC 60601-1
ASQ Certification (Quality/Reliability)
Strong communication & documentation skills.
Qualification:
Bachelors in Engineering/Science with 5+ years, or Masters with 3+ years in Quality/Engineering.
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